Side by side
Consultation participation and their own register declarations, side by side. Counts, not judgments — participation is not influence.
Counts here are a floor, never a total: they cover the 583 consultation files tracked so far (42,224 submissions, mostly 2025–26), so an organization's real filing history is larger, not smaller.
Company · France
Industry association · Belgium
Declared costs: €50K+ a year · in the register since 2009
Transitional provisions for certain medical devices and in vitro diagnostic medical devices · Electronic instructions for use for medical devices
Register facts self-declared (snapshot 2 Sept 2026); cost bands are floors. Shared files are shared attention, not evidence of coordination.
Their opening passages on the files they share, verbatim and in filing order. We do not summarize, compare, or characterize positions — read them at source.
nexialist · filed 18 Jan 2023 · source
We strongly support this legislative proposal to amend the MDR and the IVDR. However, we would like to provide several comments. MDR art 120.3 d e) It is foreseeable that the number of certification applications that the NBs will receive until May 26, 2024 (that is to say in 15 months from now) will be extremely large.
EuromContact · filed 18 Jan 2023 · source
EuromContact agrees with the initial postulate of the proposal : many devices which may be placed on the market in accordance with the initial MDR transitional provisions are not going to be certified in accordance with that Regulation before the end of the transition period, which leads to a major risk of shortages of medical devices in the EU.
nexialist · filed 25 May 2021 · source
We welcome the initiative to revise Regulation 207/2012 in order to align it with the MDR (EU) 2017/745. We appreciate the opening of a public consultation on this matter. Our comment concerns the a priori exclusion of the devices covered by Annex XVI (see art 1) Indeed, many devices of Annex XVI fall within the application criteria as described in article 3 of the draft regulation.
EuromContact · filed 25 May 2021 · source
EUROMCONTACT is the association representing the contact lens and lens care products manufacturers in the European Union. We represent more than 90% of the soft contact lens and 80% of the contact lens care products, and more than 50% of the rigid contact lenses in the European market.
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